First "Bridge to Recovery" Patient and Clinical Trial...

First "Bridge to Recovery" Patient and Clinical Trial Update

HeartWare is pleased to report the first successful "Bridge to Recovery" case using HeartWare's

HVAD
TM left ventricular assist device.

On 18th July, the heart failure team at Royal Perth Hospital led by Prof Gerry O'Driscoll (heart failure

cardiologist) and Dr Rob Larbalestier (cardiothoracic surgeon) successfully removed the HVAD
TM

device from one of their patients. The 38-year-old male patient had been implanted with his HVAD
TM

on 23rd October 2006. After 268 days or approximately 9 months of support on the device, the

patient's heart function had improved to such an extent that the Royal Perth team decided to explant

the pump.

Professor Gerry O'Driscoll commented:

"
This case presents a clear example of the potential for mechanical pumps to recover certain patients

from heart failure. The additional blood-flow provided by the implanted pump helps to unload the left

ventricle and reverse end-organ dysfunction. Over time, and with appropriate drug therapy, the

damaged heart muscle can recover and resume near-normal function. In cases such as these, the

potential to remove the pump and avoid heart transplantation is a significant advance.

Less than one year ago, this patient was critically ill. He would not have survived without either a

mechanical pump or a heart transplant. Today, at 38 years of age, he has largely overcome his heart

failure and faces the real prospect of a long and productive life.
"

The prospect of pumps being used for "bridge-to-recovery" has the potential to significantly expand

the market for these devices. Studies are currently underway to establish how best to identify potential

recovery patients and to more clearly understand the bridge to recovery opportunity.

Clinical Trial Update

Following two implants last week at St Vincent's Hospital (Sydney) and Vienna General Hospital

respectively, the HeartWare HVAD
TM has now been implanted in 18 patients.

Of these 18 patients, 17 are alive. On a cumulative basis these patients have now been supported on

the device for almost 2,600 days, or over 7 years. Of our 18 patients, 7 have successfully passed the

primary clinical endpoint of the trial. Three of these patients underwent successful heart

transplantations after being supported by their pumps for 427, 348 and 157 days respectively.

We continue to be encouraged by the clinical performance of our pump and we remain on track to

completing our twenty patient target enrolment in our CE mark clinical trial over coming weeks.